Thyroid Cancer Mutation Panel

Test Code

90469

CPT Codes
81445

Includes

BRAF Mutation Analysis, Papillary Thyroid Cancer
RAS Mutation Analysis, Thyroid Cancer
RET/PTC Rearrangement, Thyroid Cancer
PAX8/PPAR[gamma] Translocation, Thyroid Cancer

Preferred Specimen

Formalin-fixed, paraffin-embedded tissue block

Other Acceptable Specimens

Needle washing (see instructions)

Instructions

Needle washings in alcohol-based fixative (e.g. CytoLyt® or formalin-fixed, paraffin-embedded tissue block FNA or FFPE specimens are acceptable for the assay.

All specimens must be accompanied with Pathology report. All FFPE specimens will be examined by a pathologist for confirmation and adequacy. Macrodissection if warranted is performed in the lab.

Transport Temperature

Room temperature

Specimen Stability

FNA or FFPE
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable

Needle washings
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable

Methodology
See individual tests

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics Nichols Institute. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Daily; Report available: 5 days

Reference Range

BRAF Mutation Analysis, Papillary Thyroid Cancer

BRAF Mutation

Not detected

RAS Mutation Analysis, Thyroid Cancer

HRAS Mutation	Not detected
KRAS Mutation	Not detected
NRAS Mutation	Not detected

RET/PTC Rearrangement, Thyroid Cancer

RETPTC1	Not detected
RETPTC3	Not detected

PAX8/PPAR[gamma] Translocation, Thyroid Cancer

PAX8/PPAR

Not detected

Clinical Significance

The thyroid mutation panel assesses for all 8 of the most common mutations or rearrangements associated with thyroid neoplasia.

The BRAF codon 600 mutation, and RET/PTC1 and RET/PTC3 rearrangements are highly associated with papillary thyroid cancer, the PAX8-PPAR{gamma} with follicular carcinomas and RAS mutations (in either HRAS, KRAS and NRAS) usually with follicular neoplasms.

See test codes 90477 (BRAF), 90473 (RET/PTC), 90474 (PPAR/PAX8), and 90479 (RAS panel) for individual components.

A thyroid cytology diagnosis code with reflex to molecular, as appropriate, is also available.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.